Product Information File (PIF)
A Product Information File – or PIF for short – is a mandatory document required by the EU cosmetics regulation for all cosmetic products placed on the EU market. The purpose of the PIF is to capture key safety information about the cosmetic.
The PIF must contain specific information, including the product’s ingredients and quantities, lab test certificates, and safety data sheets. It must also include packaging mock-ups, as well as any post-marketing adverse reactions.
The PIF should be held on file by the Responsible Person and be available to the authorities should they request it. The PIF should be updated with any changes to the product characteristics and safety information, among other things.
The Responsible person must keep the PIF for a period of 10 years following the date of the last
batch released on to the market. The PIF must be readily accessible in electronic in a language easily understood by competent authorities. This can be either the language native to the authority making the request or English.
What should be in a Product Information File?
What is the best format for creating a Product Information File?
How do you create a Product Information File?
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We are a London-based regulatory affairs consultancy providing services to the e-cigarette, cosmetic, biocide and pharmaceutical industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and analytical testing services.
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